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Parker Quality & Compliance

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510(k) clearance

HYALOMATRIX

FDA 510(k) source

510(k) number
K261311
Applicant
Anika Therapeutics, Inc.
Decision date
Sep 2, 2026
Date received
Apr 21, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
QSZ
Device type
Absorbable Synthetic Wound Dressing
Device class
Unclassified
Advisory committee
Unknown
Statement or summary
Summary
Third party
N
Location
Beford, MA, US